This invention relates to counter mechanisms for determining the number of times a reposable or disposable device has been used or reprocessed, and indicating when the device may no longer be safe or effective to use.
Various devices used for example in medical or other applications may be limited in the number of times they can safely or effectively be used with sterilization between uses. As used herein, the term sterilization encompasses one or more of the following: sterilizing, disinfecting and cleaning. Such devices may generally degrade somewhat with each use (and subsequent sterilization) until they become unsafe or ineffective to use further. A manufacturer may validate the useful life of such devices, which should provide some margin of safety taking into account variations of the entire population.
There is thus a need to provide some means for effectively determining the number of uses of a reposable or disposable device, and indicating when the device may no longer be effective or safe to use.
The counter mechanisms of the present invention may be used to determine the number of uses of a reposable or disposable device based on one or more parameters, and may also provide an indication of when the device should no longer be used. A reposable device is one that is reusable for a limited number of times with, for example, as in the case of a medical type device, sterilization between uses.
In accordance with one aspect of the invention, the counter mechanism may be driven by an actuator that may be mechanically actuated or be an electrical or optical switch or sensor.
In accordance with another aspect of the invention, the actuator may be driven by an operator manually activating the actuator upon each use.
In accordance with another aspect of the invention, the actuator may be driven by the mechanical action of assembling mating parts of the device upon each use.
In accordance with another aspect of the invention, the actuator may be activated by electrical or mechanical sensors when specific values of one or more environmental factors are reached during sterilization of the device.
In accordance with another aspect of the invention, means may be provided for measuring for different environmental factors or parameters used to sterilize a device to determine the useful life of the device.
In accordance with another aspect of the invention, mechanical or electrical means may be provided for counting the number of actuations of the actuator.
In accordance with another aspect of the invention, the actuator may drive or move a display.
In accordance with another aspect of the invention, the display may display the number of uses of the device, or count down the number of uses left of the device.
In accordance with another aspect of the invention, the display may be graphic, or may include movable flags or pins or lights which may flash or blink to indicate or draw attention to when the device has been used a specified number of times.
In accordance with another aspect of the invention, the display may be an electronic or mechanical display.
In accordance with another aspect of the invention, the counter mechanism may include means to prevent further use of the device after a specified number of uses or cycles, for example, by interrupting electrical connections, blocking light, obstructing fluid paths, preventing assembly of components or connectors, and/or disabling mechanical linkages.
In accordance with another aspect of the invention, the counter mechanism may be incorporated into the device, or be a stand alone mechanism which attaches to or is associated with the device.
In accordance with another aspect of the invention, the counter mechanism may contain its own power supply to power electrical displays or counters.
In accordance with another aspect of the invention, the counter mechanism may include a recorder for recording specific values or parameters that one or more environmental factors attained and/or the length of time one or more environmental factors or parameters were maintained during sterilization of the device to validate that a sterilization cycle has been successfully completed.
In accordance with another aspect of the invention, a timer may be used to measure the total time a device is used or the different settings or parameters at which a device is operated, or the length of time the device is used above some specified parameter, to measure the useful life of the device.
In accordance with another aspect of the invention, the counter mechanism may be reset after a device has been refurbished or replaced to permit the counter mechanism to be put back into use to measure the useful life of the same or a different device.
In accordance with another aspect of the invention, the counter mechanism may communicate with other equipment, either to download information for permanent storage, or to receive information from another piece of equipment.
Still other aspects and/or advantages of the present invention will become apparent to those skilled in the art upon the reading and understanding of the following detailed description, accompanying drawings and appended claims. The following description and annexed drawings set forth in detail certain illustrative embodiments of the invention, these being indicative, however, of but several of the various ways in which the principles of the invention may be employed.